Therapeutic Potential of Topical Latanoprost Acid in Hair Loss - Pilot, Proof-of-concept Study

Investigation of the Effect of Cosmetic Products Containing Latanoprost Acid on Hair Condition in Women Aged 18-60 Years

This pilot study evaluates the efficacy, safety, and tolerability of topical latanoprost acid in adult women with female pattern hair loss, with a minority of participants diagnosed with chronic telogen effluvium. In this randomized, double-blind, single-center, dose-ranging trial, participants receive latanoprost acid 0.01%, 0.05%, or 0.1% applied once daily for 6 months; a small vehicle group is included to support masking and assess tolerability. The primary outcome is the within-participant change in target-area hair count (hairs/cm²) from baseline to Month 6. Secondary and exploratory outcomes include follicular-unit distribution (percent of 1-, 2-, and 3-hair units), number of yellow dots, and patient-reported outcomes.

Study Overview

• Status: Completed
• Conditions: Telogen Effluvium; Androgenetic Alopecia (AGA); Female Pattern Hair Loss, Androgenic Alopecia
• Intervention / Treatment: Other: Vehicle cosmetic topical solution (placebo comparator); Other: Latanoprost acid-containing cosmetic topical solution

Detailed Description

Detailed Description This single-center, randomized, double-blind, vehicle-controlled, dose-ranging pilot trial evaluated topical latanoprost acid in adult women with diffuse scalp hair loss consistent with female pattern hair loss (FPHL) or chronic telogen effluvium. Eligible participants were women aged 18-60 years with FPHL classified as Ludwig I-III or with chronic telogen effluvium. Key exclusion criteria included recent use of hair-growth treatments, active scalp dermatoses, or significant uncontrolled medical conditions. Forty participants were screened and 29 were enrolled.

Randomization and masking Participants were randomly assigned to one of four groups: vehicle (placebo) or latanoprost acid 0.01%, 0.05%, or 0.1%. Randomization was computer-generated. Allocation concealment was maintained using identical-appearance dropper bottles labeled with code numbers. Both participants and investigators were blinded to treatment assignment through Month 6, including during all outcome assessments. The placebo formulation consisted of the same vehicle without active latanoprost acid to ensure a comparable application experience across groups.

Intervention and study conduct Participants applied the assigned topical solution once daily for 6 months to the androgen-dependent scalp area affected by thinning. Participants were instructed to distribute the solution evenly using the dropper (2-3 mL per application as per instructions), avoid runoff, and refrain from washing the treated area for at least 8 hours after application. Usual hair-care routines (eg, shampoo and styling products) were kept constant during the study. Concomitant hair-loss therapies were prohibited throughout the treatment period.

Efficacy assessments and procedures Standardized clinical photography and trichoscopy were obtained at study visits, including baseline and follow-up assessments at Months 3 and 6. Outcome measurements were performed at standardized points within the treated region. A standardized 1 cm2 assessment field within the treated area was used to support consistent, repeatable measurements across visits. All visible hairs within the assessment field were counted to determine target-area hair count (TAHC, hairs/cm2). Trichoscopic outcomes included follicular-unit (FU) arrangement reported as the percentage of follicular units with a single hair (%FU1) and with 2 and 3 hairs (%FU2 and %FU3), as well as the number of yellow dots. Hair-shaft thickness was assessed on a 0-3 grading scale. Patient self-assessments were collected at Months 3 and 6 using a structured questionnaire addressing shedding, hair thickness/volume, and overall growth/satisfaction.

Endpoints: The prespecified primary endpoint was the within-subject absolute change in target-area hair count (ΔTAHC, hairs/cm^2) from baseline to Month 6 within the standardized assessment field. Secondary endpoints included change from baseline to Month 6 in hair-shaft thickness grade, follicular-unit (FU) arrangement (%FU1, %FU2, %FU3), and patient-reported outcomes collected using a structured questionnaire. Exploratory endpoints included dermoscopic markers, in particular change from baseline in the number of yellow dots assessed at Months 3 and 6.

Safety and tolerability Safety and tolerability were assessed at each visit through systematic adverse event collection, targeted scalp examination (including evaluation for erythema and irritation), and measurement of vital signs. Safety monitoring covered local scalp findings and any systemic effects during the 6-month treatment period.

• Study Type: Interventional
• Enrollment (Actual): 29
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria

• Female participants aged 18-60 years
• Diffuse scalp hair loss consistent with female pattern hair loss (FPHL), Ludwig grade I-III, or chronic telogen effluvium
• Willingness to comply with all study procedures

Exclusion Criteria

• Recent use of other hair-growth treatments
• Active dermatologic conditions affecting the scalp (active scalp dermatoses)
• Significant uncontrolled medical conditions

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Vehicle cosmetic topical solution (placebo comparator); Participants applied the vehicle topical solution (without latanoprost acid) once daily for 6 months to the androgen-dependent scalp area affected by thinning hair. The solution was administered using a dropper to distribute approximately 2-3 mL evenly, avoiding runoff, and participants were instructed not to wash the treated area for at least 8 hours after application. Concomitant hair-loss therapies were prohibited and usual hair-care routines were kept constant.	Other: Vehicle cosmetic topical solution (placebo comparator); Matching vehicle-only cosmetic topical solution without latanoprost acid. The product was dispensed in identical, coded dropper bottles to maintain blinding. Participants applied the vehicle cosmetic solution once daily for 6 months to the androgen-dependent scalp area affected by thinning hair, distributing approximately 2-3 mL evenly, avoiding runoff, and refraining from washing the treated area for at least 8 hours post-application. Concomitant hair-loss treatments were prohibited and usual hair-care routines were kept constant during the study.
Experimental: Latanoprost acid-containing cosmetic topical solution (0.01%); Participants applied latanoprost acid 0.01% in vehicle once daily for 6 months to the androgen-dependent scalp area affected by thinning hair. The solution was administered using a dropper to distribute approximately 2-3 mL evenly, avoiding runoff, and participants were instructed not to wash the treated area for at least 8 hours after application. Concomitant hair-loss therapies were prohibited and usual hair-care routines were kept constant.	Other: Latanoprost acid-containing cosmetic topical solution; Topical cosmetic solution containing latanoprost acid, evaluated at concentrations of 0.01%, 0.05%, and 0.1% in a vehicle formulation, with a matching vehicle-only cosmetic solution used as placebo comparator. The cosmetic solution was dispensed in identical, coded dropper bottles to maintain blinding. Participants applied the assigned cosmetic solution once daily for 6 months to the androgen-dependent scalp area affected by thinning hair, distributing approximately 2-3 mL evenly, avoiding runoff, and refraining from washing the treated area for at least 8 hours post-application. Use of concomitant hair-loss treatments was prohibited and usual hair-care routines were kept constant during the study.
Experimental: Latanoprost acid-containing cosmetic topical solution (0.05%); Participants applied latanoprost acid 0.05% in vehicle once daily for 6 months to the androgen-dependent scalp area affected by thinning hair. The solution was administered using a dropper to distribute approximately 2-3 mL evenly, avoiding runoff, and participants were instructed not to wash the treated area for at least 8 hours after application. Concomitant hair-loss therapies were prohibited and usual hair-care routines were kept constant.	Other: Latanoprost acid-containing cosmetic topical solution; Topical cosmetic solution containing latanoprost acid, evaluated at concentrations of 0.01%, 0.05%, and 0.1% in a vehicle formulation, with a matching vehicle-only cosmetic solution used as placebo comparator. The cosmetic solution was dispensed in identical, coded dropper bottles to maintain blinding. Participants applied the assigned cosmetic solution once daily for 6 months to the androgen-dependent scalp area affected by thinning hair, distributing approximately 2-3 mL evenly, avoiding runoff, and refraining from washing the treated area for at least 8 hours post-application. Use of concomitant hair-loss treatments was prohibited and usual hair-care routines were kept constant during the study.
Experimental: Latanoprost acid-containing cosmetic topical solution (0.1%); Participants applied latanoprost acid 0.1% in vehicle once daily for 6 months to the androgen-dependent scalp area affected by thinning hair. The solution was administered using a dropper to distribute approximately 2-3 mL evenly, avoiding runoff, and participants were instructed not to wash the treated area for at least 8 hours after application. Concomitant hair-loss therapies were prohibited and usual hair-care routines were kept constant.	Other: Latanoprost acid-containing cosmetic topical solution; Topical cosmetic solution containing latanoprost acid, evaluated at concentrations of 0.01%, 0.05%, and 0.1% in a vehicle formulation, with a matching vehicle-only cosmetic solution used as placebo comparator. The cosmetic solution was dispensed in identical, coded dropper bottles to maintain blinding. Participants applied the assigned cosmetic solution once daily for 6 months to the androgen-dependent scalp area affected by thinning hair, distributing approximately 2-3 mL evenly, avoiding runoff, and refraining from washing the treated area for at least 8 hours post-application. Use of concomitant hair-loss treatments was prohibited and usual hair-care routines were kept constant during the study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in target-area hair count (TAHC)	Within-participant absolute change in target-area hair count (TAHC, hairs/cm^2) from baseline to Month 6, measured within a standardized 1 cm^2 assessment field within the treated scalp region using standardized photography and trichoscopy.	Baseline to Month 6

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in hair-shaft thickness grade (0-3)	Change from baseline to Month 6 in hair-shaft thickness grade assessed on standardized trichoscopic images obtained from standardized assessment points within the treated region. Scale title: Hair-shaft thickness grade scale. Scale range: 0 (minimum) to 3 (maximum). Higher scores indicate greater hair-shaft thickness.	Baseline to Month 6
Change from baseline in follicular-unit (FU) arrangement (%FU1, %FU2, %FU3)	Change from baseline to Month 6 in follicular-unit arrangement assessed by trichoscopy as the percentage of follicular units with single hair (%FU1) and with 2 hairs (%FU2) and 3 hairs (%FU3) within standardized assessment points in the treated region.	Baseline to Month 6
Change from baseline in number of yellow dots	Change from baseline in the number of yellow dots assessed by trichoscopy within standardized assessment points in the treated region; evaluated at Month 3 and Month 6.	Baseline, Month 3, and Month 6
Patient-reported outcomes (shedding, thickness, overall growth)	Patient self-assessment of shedding, perceived hair thickness, and overall hair growth collected using a structured questionnaire.	Month 3 and Month 6
Safety and tolerability: adverse events	Incidence and severity of adverse events (AEs) collected at study visits through systematic adverse event monitoring during the 6-month treatment period.	Up to 6 months (baseline through Month 6)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent change from baseline in target-area hair count (TAHC)	Percent change from baseline to Month 6 in target-area hair count (TAHC, hairs/cm^2) within the standardized assessment field.	Baseline to Month 6

Collaborators and Investigators

• Sponsor: Medical University of Warsaw
• Investigators: Study Director: Katarzyna A Koziak, Professor, Medical University of Warsaw

Study record dates

Study Major Dates

• Study Start (Actual): July 8, 2015
• Primary Completion (Actual): July 8, 2016
• Study Completion (Actual): July 8, 2016

Study Registration Dates

• First Submitted: February 2, 2026
• First Submitted That Met QC Criteria: February 8, 2026
• First Posted (Actual): February 17, 2026

Study Record Updates

• Last Update Posted (Actual): February 17, 2026
• Last Update Submitted That Met QC Criteria: February 8, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Female pattern hair loss (FPHL); Trichoscopy; latanoprost acid; Follicular unit remodeling
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Skin Diseases; Hypotrichosis; Hair Diseases; Pathological Conditions, Signs and Symptoms; Skin and Connective Tissue Diseases; Alopecia
• Other Study ID Numbers: KB/148/2015

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data (IPD) will not be shared with other researchers. IPD will not be made available to protect participant privacy and confidentiality and due to the small sample size, which may increase the risk of re-identification. Only aggregate, de-identified results will be reported.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No